Clinical trials: BALANCE
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01827865
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Pulmonary Arterial Hypertension
Absorption, Distribution, Metabolism and Excretion of BIA 5-1058
the purpose of this study is: to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7…
- Trial name
- ADME (NCT04991181)
- Testing
- 400 mg BIA 5-1058
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Arthritis, Psoriatic
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this…
- Trial name
- OPAL BALANCE (NCT01976364)
- Testing
- Tofacitinib, Methotrexate
- Where
- 153 sites in United States, Australia and 14 more
- Volunteers
- 686 people
- Sponsor
- Pfizer
Healthy Participants
A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth.
- Trial name
- NCT07812077
- Testing
- [14C]AZD4954 Oral Solution, AZD4954 film-coated tablet, [14C]AZD4954 Solution for Infusion
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2.
- Trial name
- NCT01133483
- Testing
- Fexofenadine HCl + Pseudoephedrine HCl
- Where
- India
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled…
- Trial name
- NCT02252354
- Testing
- [14C]-TAK-385 Oral Solution, TAK-385 Tablets, [14C]-TAK-385 Solution for Intravenous Infusion
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Vaginal Health, Vaginal pH
A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its…
- Trial name
- NCT06516731
- Testing
- pH Balanced Cleanser
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Love Wellness
Healthy
Study of Radiolabeled ALXN2050 in Healthy Adult Males
This is an open-label study to assess the absorption, metabolism, excretion, and mass balance of a single oral dose of carbon-14 ([14C])-ALXN2050 in healthy adult males.
- Trial name
- NCT04609670
- Testing
- [14C]-ALXN2050
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
TB
Pharmacokinetic Study of Sudapyridine（WX-081）in Healthy Chinese Subjects
This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of [U-14C] WX-081 in healthy Chinese male…
- Trial name
- NCT06701110
- Testing
- [U-14C] WX-081
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
Premenstrual Syndrome
Effects of a Female Hormone Balance Supplement on Premenstrual Syndrome Symptoms
This virtual single-group study evaluates the effects of the FemmeBalance supplement on symptoms of premenstrual syndrome (PMS) over four menstrual cycles.
- Trial name
- NCT07018479
- Testing
- FemmeBalance Supplement Group
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- VINABAS FORMULATIONS SL
Healthy Participants
A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants
The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity…
- Trial name
- NCT06301971
- Testing
- Emraclidine
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Critical Illness, Post Operative Complication
Safety and Feasibility of a Self-Balancing Exoskeleton for Rehabilitation in the Thoracic Surgical Intensive Care Unit: a Pilot Trial
Patients admitted to the Intensive Care Unit (ICU) after thoracic surgery often experience complications related to immobility, such as muscle weakness, pulmonary issues, and longer recovery times.
- Conditions
- Critical Illness, Post Operative Complication, Thoracic Surgery
- Trial name
- HEART (NCT07220733)
- Testing
- Self-balancing robotic exoskeleton (Atalante X)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Wandercraft
Hyponatremia
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.
- Trial name
- NCT00578695
- Testing
- lixivaptan
- Where
- 287 sites in United States, Argentina and 13 more
- Volunteers
- 652 people
- Sponsor
- CardioKine Inc.
Vaginosis, Bacterial, Bacterial Vaginosis
Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis
The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections.
- Conditions
- Vaginosis, Bacterial, Bacterial Vaginosis, Bacterial Vaginosis (BV)
- Trial name
- GYNBAL-RBV (NCT07527572)
- Testing
- Lactobacillus gasseri KABP®064 10e9 CFU/capsule
- Volunteers
- 160 people
- Sponsor
- Kaneka Americas Holding Inc.
Healthy
Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects
A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.
- Trial name
- ARIADME (NCT02418650)
- Testing
- ODM-201 300 mg tablet, intravenous14C-ODM-201, 300 mg 14C-ODM-201 oral solution
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal…
- Trial name
- NCT01053208
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl
This is an open-label study to evaluate the PK and excretion of a single oral dose of [14C]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days prior to dosing); a treatment phase (from dosing…
- Trial name
- NCT05006118
- Testing
- Radio-labeled rodatristat ethyl 600 mg
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Altavant Sciences GmbH
Dry Eye Syndrome, Lipid Deficiency
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
- Trial name
- NCT01688726
- Testing
- SYSTANE® BALANCE eyedrops, Minims® Saline 0.9% eyedrops
- Volunteers
- 91 people
- Sponsor
- Alcon Research
Health Volunteers
An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects
This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.
- Trial name
- NCT01765855
- Testing
- Betrixaban single oral dose
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Healthy Participants
A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants
This study is conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-INCB161734 in healthy male participants.
- Trial name
- NCT07814404
- Testing
- INCB161734
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation